SAM #36C26026Q0807

Specialized NGS-Based MRD Testing Services for Hematologic Malignancies – VA Portland

This opportunity is for specialized laboratory testing services for Measurable Residual Disease (MRD) detection in hematologic malignancies, managed by the Department of Veterans Affairs, Network Contracting Office 20, for the Portland VA Medical Center and associated clinics. - Government Buyer: - Department of Veterans Affairs - Network Contracting Office 20 - Portland VA Medical Center - Products/Services Requested: - FDA-cleared, next generation sequencing (NGS)-based MRD assays for multiple myeloma, chronic lymphocytic leukemia (CLL), and B-cell acute lymphoblastic leukemia (B-ALL) - Testing on blood, bone marrow, and FFPE tissue samples - Estimated annual utilization: 10 tests - Reference laboratory services including specimen testing, interpretation, reporting, customer service, technical support, and supply provision - Secure electronic results delivery and customer-accessible results portal - Unique/Notable Requirements: - Testing must be performed in CLIA-certified and CAP-accredited laboratories - Turnaround time of 6 business days for results - Compliance with all federal, state, and local regulations and accreditation standards - Provision of specimen containers, collection kits, requisition forms, and reporting services - No specific OEMs or vendors are named in the solicitation, but the requirement for FDA-cleared NGS-based MRD assays highlights the need for highly specialized laboratory capabilities.

Description

STATEMENT OF WORK (SOW) for Reference Laboratory Services for specialized testing for Measurable Residual Disease (MRD) detection in hematologic malignancies BACKGROUND The VA Portland Healthcare System (VHAPORHCS) Pathology & Laboratory Medicine Service Department requires continued access to specialized testing for Measurable Residual Disease (MRD) detection in hematologic malignancies. MRD is a powerful diagnostic and prognostic tool that quantifies the presence of residual cancer cells during and after treatment in patients with multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), and chronic lymphocytic leukemia (CLL). The contractor shall provide MRD testing of an FDA-cleared, next generation sequencing (NGS)-based assay for blood and bone marrow samples from patients diagnosed with multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and B-cell acute lymphoblastic leukemia (B-ALL). Testing shall be performed at the contractor's CLIA-certified (requirement) and CAP-accredited (or equivalent; requirement) reference laboratory and include full interpretation and reporting of results to VHAPORHCS clinicians. This full-service Reference Laboratory contract will provide services required for specimen testing, interpretation, testing supplies, and customer service. This requirement will ensure accurate and timely test results are made available to healthcare providers, which will ensure high-quality healthcare is provided to the Veterans at the VA Portland Health Care System. SCOPE The objective of this agreement is to provide VHAPORHCS with access to FDA-cleared and clinically validated MRD testing to support direct patient care within the Hematology/Oncology and Pathology and Laboratory Medicine Services (PALMS), ensuring accurate disease monitoring and outcome assessment for veterans undergoing cancer therapy. The contractor shall: Provide MRD testing for the following specimen and disease types: Bone marrow aspirate or peripheral blood for: Multiple Myeloma (MM) Chronic Lymphocytic Leukemia (CLL) B-cell Acute Lymphoblastic Leukemia (B-ALL) FFPE Bone Marrow tissue (as applicable) Please see Attachment A to this Statement of Work (SOW) for the test and quantities required by VAPORHCS. Perform testing within the contractor's CLIA-certified, CAP-accredited (or equivalent) laboratory using FDA-cleared protocols. Provide an average turnaround time of 6 business days from receipt of specimen. Provide secure electronic results via a vendor-managed portal and fax reports directly to designated VA clinicians. Maintain a customer-accessible results portal for tracking orders and retrieving historical patient data. Provide technical support for order management and result interpretation. Ensure all testing is performed using validated instruments, reagents, and methodologies per FDA clearance and CLIA/CAP (or equivalent) standards. The Reference Laboratory shall also provide support services: supplies, customer service, reporting services, and verification of certification. All necessary supplies as defined in the laboratory user manual include, but are not limited to: Requisition forms or agreed computer ordering system Specimen containers & collection kits Specimen requirements for collection & processing Methodologies and reference ranges Expected turn-around times All forms, including authorization of consent for genetic testing, informed consent, and chain of custody The VAPORHCS requires that the Reference laboratory provide technical and consultative support related to any results provided by the vendor. The vendor shall identify on Attachment A whether testing is performed in-house or sent out/referred to an alternate lab, not owned by the vendor. Clinical Application and Importance The MRD assay is clinically essential for identifying and quantifying MRD in patients treated for hematologic malignancies. MRD detection is a powerful biomarker for determining remission depth and relapse risk, directly impacting: Treatment continuation or modification (chemotherapy, transplant, immunotherapy decisions) Clinical trial eligibility and disease response categorization Prognostic evaluation for relapse-free and overall survival outcomes For VHAPORHCS patients, MRD testing allows Hematologists/Oncologists to make data-driven treatment decisions, prevent unnecessary toxicity from ineffective therapies, and improve long-term survival rates. These testing services are an integral component of direct patient care activities within the VHAPORHCS Hematology and Oncology Service and are performed in coordination with laboratory and clinical teams. Deliverables The Reference Laboratory shall perform testing available at their site as requested by VA Portland Health Care System (VAPHCS). Testing results for each submitted sample. The specimen will be logged into the system within 24 hours of receipt. VAPHCS will be notified if specimens are sub-optimal for testing within 24 hours of receipt at their facility. Timely reporting of results in a format compatible with PALMS and clinical workflows. A final report will be issued on the same day the test is complete and no later than 24 hours after testing is completed. Documentation of quality control and laboratory compliance records as requested by the VA. Acceptance Criteria All test results must meet established clinical laboratory standards. Test results must be delivered in a timely manner compatible with patient care needs and PALMS integration. Reports must be accurate, complete, and actionable for the ordering clinician. Please see Attachment A to this Statement of Work (SOW) for the test and quantities required by VAPORHCS. Other Pertinent Information Identification of Possible Follow-on Work: None Identification of Potential Conflicts of Interest (COI): None Identification of Non-Disclosure Requirements: This medical center provides specific privacy to patients as part of its normal protocols. Packaging, Packing and Shipping Instructions: Specimens will be packaged and shipped in accordance with Department of Transportation regulations for the shipment of biologic substances. Inspection and Acceptance Criteria: Reference Laboratory shall notify the VAPHCS Department of Pathology and Laboratory Medicine of any specimens that do not meet the requirements for acceptance. Risk Control: None. Place of Performance: Reference Laboratory defined at award Period of Performance: Estimated Contract Period of Performance is: Ordering Period 1: 9-1-26 to 8-31-27 Ordering Period 2: 9-1-27 to 8-31-28 Ordering Period 3: 9-1-28 to 8-31-29 Ordering Period 4: 9-1-29 to 8-31-30 Ordering Period 5: 9-1-30 to 8-31-31 Testing Methodology, Reference and Turnaround Time Routine test results shall be reported within the specified turnaround time (TAT), defined from specimen pickup to results availability. TAT is established by the VA facility. If testing exceeds TAT, notify the VA facilities of the new estimated TAT within 24 hours. Testing methodology and reference ranges must be defined in the Reference Laboratory user manual and/or website. The Reference Laboratory shall advise the facility of any changes in methodology, procedure, reference ranges, and new tests 30 days in advance. The Reference Laboratory agrees to maintain minimum acceptable service, reporting systems, and quality control. Exception handling: The Reference Laboratory will notify VA Laboratory Service within 24 hours of any problems with specimens received. The VA Facilities will provide laboratory specimens prepared according to the Reference Laboratory's user manual, identified, and labeled for testing. Critical Value test results are not applicable. The Reference Laboratory shall provide testing in accordance with all applicable regulations and accreditation standards. All requirements and provisions in this solicitation apply to any laboratory performing reference testing on behalf of the Reference Laboratory. The above is an estimated list of testing services needed, but not limited to. Due to the nature of patient care, there may be times when a test not listed is required, such as new methodologies, discovery of new antigens or antibodies, or urgent patient needs. The included test list is an estimate and not all-inclusive. Specimen types include blood, bone marrow, and FFPE tissue blocks. If new products or testing services are required, the Contracting Office will determine if they are within scope, and a contract modification will be necessary prior to beginning new testing services. Customer Service The Reference Laboratory will provide VA Laboratory with a communication means for immediate inquiries regarding test status or specimen issues, available 24/7. The Reference Laboratory shall provide contact information for technical Directors and Pathologists available for consultation. Delivery and Reporting Billing summaries shall begin the first day of the month and include the last day of the month. Tests referred to another laboratory shall incur no additional transfer or confirmation charges to the government. Deliveries must include a delivery ticker or sales slip with: Vendor Name Applicable FSS contract number Contract, Task order, and Purchase Order numbers Date of Purchase Date of Shipment Description of item Quantity of each item Unit price and extended price The Reference Laboratory shall provide an end-of-year report on sample issues, facility usage, and cost savings, due 45 days after year-end. Invoicing shall be monthly, with itemized details including contract number, purchase order, service date, patient name, test, and costs. Invoices are to be submitted electronically via Tungsten, with specific requirements outlined. Performance Monitoring At contract award, a Contracting Officer will appoint a COR to monitor service quality, TATs, billing, customer service, and proficiency testing. The contractor shall provide proficiency reports 90 days before each contract period's end, maintaining at least a 95% success rate. Failure to do so may result in termination. The COR will ensure services comply with contract terms and will report any non-compliance immediately. Joint reviews will be conducted prior to contract expiration to evaluate service quality and compliance. Licensing and Accreditation The contractor shall provide copies of all required licenses, permits, and accreditation, including a licensed pathologist/laboratory director. All facilities must meet CLIA and CMS requirements and be CAP-accredited or equivalent. Personnel Employees must have current professional certifications and meet CLIA '88 guidelines. The government may request verification of compliance, and non-compliance may lead to contract termination. Hours of Operation The Portland VA operates 24/7 and may require services at any time. Patient Information Safety VAPORHCS will provide PHI with each specimen, including full name, medical record number, SSN, DOB, provider's name, accession number, specimen type, and collection date/time. The Reference Laboratory shall safeguard this information, report breaches immediately, and mitigate any harm. Security Requirements The contractor shall adhere to VA security policies, including periodic monitoring, background investigations, secure handling of VA information, encryption, and incident reporting. The contractor shall cooperate with VA security assessments and comply with all applicable laws and directives. Records Management The contractor shall comply with all federal records laws, maintain proper records, and ensure secure handling, storage, and destruction of VA data. Unauthorized removal or destruction of records is prohibited and subject to penalties. All data and records produced are property of the U.S. Government. Attachment A Includes an estimated list of testing services, test codes, names, utilization, prices, costs, and testing locations. The vendor must provide test results within the specified turnaround times and meet licensing and certification requirements, with the ability to process blood, bone marrow, and FFPE tissue blocks.

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